Usual Adult Dose for Reversal of Acquired Coagulation Factor Deficiency

INR 2 to less than 4: 25 units of Factor IX/kg body weight given intravenously
INR 4 to 6: 35 units of Factor IX/kg body weight given intravenously
INR greater than 6: 50 units of Factor IX/kg body weight given intravenously

Maximum dose:
INR 2 to less than 4: 2500 units of Factor IX
INR 4 to 6: 3500 units of Factor IX
INR greater than 6: 5000 units of Factor IX

Duration of therapy: Single dose. Repeat dosing is not supported by clinical data and is not recommended.

Comments:

• Administer Vitamin K concurrently to maintain Vitamin K dependent clotting factor levels once the effects of prothrombin complex concentrate have diminished.
• Individualize dosing based on the patient's current predose International Normalized Ratio (INR) value, and body weight.
• Dose is based on body weight up to but not exceeding 100 kg. Do not exceed stated maximum dose for patients weighing more than 100 kg.
• Dosing is based on actual potency. The potency varies from vial to vial and is stated on the carton. Potency varies from 20-31 Factor IX units/mL. Nominal potency is 500 units per vial or approximately 25 units per mL after reconstitution.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

US BOXED WARNING:

• ARTERIAL AND VENOUS THROMBOEMBOLIC COMPLICATIONS: Patients being treated with vitamin K antagonist (VKA) therapy have underlying disease states that predispose them to thromboembolic events. The potential benefits of reversing VKA therapy should be weighed against the potential risks of thromboembolic events, especially in patients with a history of such an event. Resumption of anticoagulation should be carefully considered as soon as the risk of thromboembolic events outweighs the risk of acute bleeding. Fatal and nonfatal arterial and venous thromboembolic complications have been reported with this drug in clinical trials and postmarketing surveillance. Monitor patients receiving this drug for signs and symptoms of thromboembolic events. This drug was not studied in subjects who had a thromboembolic event, myocardial infarction, disseminated intravascular coagulation, cerebral vascular accident, transient ischemic attack, unstable angina pectoris, or severe peripheral vascular disease within the prior 3 months, and therefore, may not be suitable in patients with thromboembolic events within the past 3 months.

Dialysis

Data not available

Other Comments

Administration advice:
Consult with manufacturer's product information for complete administration instructions.

Storage requirements:
Store between 36 to 77 degrees Fahrenheit (2 to 25 degrees Celsius). Do not freeze. Protect from light.

Reconstitution/preparation techniques:
Consult with manufacturer's product information for complete reconstitution instructions.

IV compatibility:
Do not mix prothrombin complex concentrate with other medicinal products; administer through a separate infusion line.

Monitoring:

• Monitor INR and clinical response during and after treatment.
• Monitor for signs and symptoms of thromboembolic events.